Components of Participating Organizations
Center for Biologics Evaluation and Research
(CBER)
Center for Drug Evaluation and Research
(CDER)
Center for Devices and Radiological
Health (CDRH)
Center for Veterinary Medicine (CVM)
Center for Food Safety and Applied
Nutrition (CFSAN)
Office of Orphan Products Development (OPD)
Office of Regulatory Affairs

Title:FDA
Small Scientific Conference Program (R13/U13)Note: The policies, guidelines, terms, and conditions stated in this
announcement may differ from those used by the NIH.

Announcement Type
New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement
(FOA) for Federal assistance must be submitted electronically through
Grants.gov (http://www.grants.gov) using
the SF424 (R&R) forms and SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE
SUBMITTED IN PAPER FORMAT.

This FOA must be read in
conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called
Grants.gov/Apply).

A registration process with Grants.gov
and eRA Commons is necessary before submission and applicants are highly
encouraged to start the process at least four weeks prior to the grant
submission date. See Section
IV.

Key Dates
Release/Posted
Date: April 8, 2008
Opening Date: May, 1, 2008 (Earliest date an application may be submitted
to Grants.gov)Letters of Intent Receipt Date(s):Not ApplicableNOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). ApplicationSubmission/Receipt
Date(s): October 15; January 15; April 15; July
15Expiration Date: July 16, 2011
Note: For some conference
grant applications, the time from submission to funding is shorter than the
regular cycle. A second level of review by a Board/Council is not required for
applications with budgets less than $50,000 total costs; therefore, funding
selections may be made sooner than the cycle indicated above.

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity provides updated guidelines for the Food and Drug
Administration support of conferences and scientific meetings.

Because the
nature and scope of the proposed activities will vary from application to
application, it is anticipated that the size and duration of each award
will also vary. The total amount awarded and the number of awards will
depend upon the number of applications, quality, duration, and costs of
the applications received.

Eligible
organizations include: For-profit organizations; Non-profit organizations;
Public or private institutions, such as universities, colleges, hospitals,
and laboratories; Units of State governments; Units of Local governments;
Eligible agencies of the Federal Government; Domestic
institutions/organizations; Faith-based or community–based organizations.
Units of State Tribal government and Units of local Tribal governments.

Foreign
institutions are not eligible to apply for conference grant support. An
international conference can be supported through the U.S. representative organization of an established international scientific or professional
society.

Any
individual with the skills, knowledge, and resources necessary to conduct
the proposed conference or scientific meeting is invited to work with that
individual’s institution to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are encouraged to apply.

Applicants
may submit more than one application, provided they propose scientifically
distinct conferences or scientific meetings.

FDA Centers
will not accept multiple applications for a single scientific meeting.

Advance
permission to submit an application must be requested early in the process
and no later than six weeks before the application submission date. The
letter from the FDA Conference Grant Contact (http://grants.nih.gov/grants/guide/contacts/parent_R13_U13.html)
documenting advance permission to submit an application must be included
with the application. Attach the letter as part of the Cover Letter
component.

Resubmissions. Applicants may
submit a “resubmission” application, but such application must include an
“Introduction” (limited to one page) addressing
the previous peer review critique (Summary Statement).

The FDA recognizes the value of supporting high quality conferences/scientific
meetings that are relevant to its scientific mission and to the public health.
A conference/scientific meeting is defined as a gathering, symposium, seminar,
scientific meeting, workshop or any other organized, formal meeting where
persons assemble to coordinate, exchange, and disseminate information or to
explore or clarify a defined subject, problem, or area of knowledge. Support of
such meetings is contingent on the fiscal and programmatic interests and
priorities of the individual Centers, which are linked to the FDA Grant Web
site http://www.fda.gov/ Therefore, a
conference grant application is required to contain a letter from the
appropriate FDA staff (see Contacts List)
documenting advance permission. Investigators are urged to initiate contact
well in advance of the application receipt date. Please note that agreement to
accept an application does not guarantee funding.

FDA Conference Grant program
information can be obtained from the Grants Management Team at 301 – 827-7168

This funding opportunity will use the Conference/Scientific
Meeting (R13 /U13) grant award mechanisms. Under the R13 mechanism, the applicant will be solely responsible
for planning, directing, and executing the proposed project. Multiple year awards may be made to a permanently sponsoring organization for
conferences held annually or biennially on a recurring topic. The total project
period for an application requesting support may not exceed five years.

The FDA U13 is a cooperative
agreement award mechanism. Under the U13 mechanism, the Project
Director/Principal Investigator (PD/PI) retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project, with
FDA staff being substantially involved as a partner with the PD/PI, as
described in Section
VI.2.A.

This funding opportunity uses just-in-time budget concepts. It also uses
the non-modular budget format. Applicants must complete and submit a detailed
categorical budget as described in Section 4.7 of the SF424 (R&R) Application
Guide.

2. Funds Available

Because the nature and scope of the proposed activities will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. The total amount awarded and the number of awards
will depend upon the number of applications, quality, duration, and costs of
the applications received.

Section III.
Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Application(s) may be submitted by an organization that has any of the
following characteristics:

For-profit
organizations

Non-profit
organizations

Public or
private institutions, such as universities, colleges, hospitals, and
laboratories

Units of
State government

Units of
local government

Eligible
agencies of the Federal government

Domestic
Institutions

Faith-based
or community-based organizations

Units of
State Tribal governments

Units of
Local Tribal governments

Foreign institutions are not
eligible to apply for conference grant support. An international conference can
be supported through the U.S. representative organization of an established
international scientific or professional society.

1.B. Eligible
Individuals

Any individual with the
skills, knowledge, and resources necessary to conduct the proposed conference
is invited to work with that individual’s institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for FDA
programs.

Most Centers will accept applications for up to five years when a series of
annual or biannual meetings is proposed by a permanently sponsoring
organization. Support for meetings held on a less frequent schedule must be
applied for individually.

Section IV.
Application and Submission Information

Registration and Instructions for Submission
via Grants.gov

FDA is accepting new applications for
this program electronically via www.grants.gov.
To download the SF424 (R&R) Application forms and
SF424 (R&R) Application Guide for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that site.

The PD/PI on the application must
also be registered in the eRA Commons.

Applicants should not share a
Commons account for both an Authorized Organization Representative/Signing
Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

Both the PD/PI(s) and AOR/SO need separate accounts
in the eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is already registered in the eRA Commons, another
registration to apply for an FDA opportunity is not necessary.

Individual DUNS and CCR registration should be used
only for the purposes of personal reimbursement and should not be used on any
grant applications submitted to the Federal Government.

Several of the steps of the registration process
could take four weeks or more. Therefore, applicants should immediately check
with their business official to determine whether their
organization/institution is already registered in both Grants.gov and the Commons. The FDA will accept
electronic applications only from organizations that have completed all
necessary registrations.

Note: For some conference
applications, the PD/PI identified is not an employee of the applicant
organization. For other conferences, the PD/PI is an employee of the applicant
organization. Therefore, for electronic receipt, applicants have the following
two options:

a) Conference applicant
organizations/institutions can name a scientific director who is an employee of
the organization/institution and register that individual in the Commons. It is
important to note that only the named scientific director at the institution
will be able to access the Summary Statement, priority score, etc. If the
applicant names someone else to be the scientific director for the conference,
the applicant organization is responsible for sharing that information with the
other individual (PD/PI).

b). Conference
applicants/institutions may continue to use an "affiliated"
individual as the PD/PI. In this case, the applicant organization will need to
officially affiliate the PD/PI with the conference organization in the Commons.

Following are the steps to
affiliate a PD/PI to an institution:

1) PD/PI gives Commons user
ID and email address to the administrator of the new institution. (The email
address must be the one that is contained in the Personal Profile for the PI.)

2) Administrator logs into
the Commons. (The administrator can be the Signing Official, Administrative
Official, or the Accounts Administrator.)

Note: The
account cannot have any other roles attached to it other than the PD/PI.

1. Request Application
Information

Applicants must download the SF424 (R &R) application forms and SF424
(R&R) Application Guide for this FOA through http://www.grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA); although some of the
"Attachment" files may be useable for more than one FOA.

Special
instructions for applicants who are submitting a renewal or revision: Applicants submitting a renewal
or resubmission are required to enter the previous grant number into the
Federal Identifier field in the SF424 (R&R) Cover Component form (box #8).
Renewal and resubmission applications that do not include this number will
receive an error. Applicants should log on to the eRA Commons to obtain
the previous grant number. If the number is not available in Commons, contact Marc
Pitts, 301- 827-7162 at FDA to get the previous grant number in order
to submit the application. Visit http://era.nih.gov/ElectronicReceipt/resubmission_FAQ.htm for additional information.

Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical
to submitting a complete and accurate application to FDA. There are fields
within the SF424 (R&R) application components that, although not marked as
mandatory, are required by FDA (e.g., the “Credential” log-in field of the
“Research & Related Senior/Key Person Profile” component must contain the
PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for
such fields are clearly identified in the Application Guide. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R) application has several
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

3.A. Submission, Review and Anticipated
Start Dates
Release/Posted
Date: April 8, 2008
Opening Date: May 1, 2008 (Earliest date an application may be submitted
to Grants.gov)Letters of Intent Receipt Date(s):Not ApplicableNOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). ApplicationSubmission/Receipt
Date(s): October 15; January 15; April 15; July, 15Expiration Date: July 16, 2011

3.A.1. Letter of Intent

A letter of intent is not required for the funding
opportunity.

3. B. Submitting an Application Electronically to the FDA

To submit an application in
response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications in response to this FOA may only be submitted to
Grants.gov through Grants.gov/Apply.

PAPER APPLICATIONS WILL NOT
BE ACCEPTED.3. C. Application Processing

Applications may be
submitted on or after the opening date and must be successfully received
by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application
submission/receipt date(s). (See Section
IV.3.A. for all dates.) If an application is not submitted by
the receipt date(s) and time, the application may be delayed in the review
process or not reviewed.

Once an application package
has been successfully submitted through Grants.gov, any errors have been addressed,
and the assembled application has been created in the eRA Commons, the PD/PI
and the Authorized Organization Representative/Signing Official (AOR/SO) have
two business days to view the application image.

If
everything is acceptable, no further action is necessary. The application
will automatically move forward for processing after two business days.

Prior to
the submission deadline, the AOR/SO can “Reject” the assembled application
and submit a changed/corrected application within the two day viewing
window. This option should be used if the AOR/SO determines that warnings
should be addressed or if information was lost or compromised during
transmission. Reminder: warnings do not stop further application
processing. If an application submission results in warnings (but no
errors), it will automatically move forward after two business days if no
action is taken. Please remember that some warnings may not be applicable
or may need to be addressed after application submission.

If the two
day window falls after the submission deadline, the AOR/SO will have the
option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best
course of action. FDA will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the
AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted but it will be
subject to the NIH/FDA
late policy guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment. Late applications may be accepted under extreme circumstances beyond the
control of the applicant. Applications not received on time will not be
considered for review and will generally be returned to the applicant.

Both the AOR/SO
and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process
after two days.

Upon receipt, applications
will be evaluated for completeness. Incomplete applications will not be
reviewed.

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

FDA will not accept any
application in response to this FOA that is essentially the same as one
currently pending initial merit review unless the applicant withdraws the
pending application. FDA will not accept any application that is essentially
the same as one already reviewed. This does not preclude the submission of an
application already reviewed with substantial changes, but such application
must include an Introduction (limited to one page)addressing the previous critique. Note, such an application
is considered a "resubmission" for the SF424 (R&R).

Pre-Award Costs are
allowable. A grantee may, at its own risk and without FDA prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing renewal (formerly,
“competing continuation”) award if such costs: are necessary to conduct the
project, and would be allowable under the grant, if awarded, without FDA prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain FDA approval before incurring the cost. FDA prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or
non-competing award imposes no obligation on FDA either to make the award or to
increase the amount of the approved budget if an award is made for less than
the amount anticipated and is inadequate to cover the pre-award costs incurred.
FDA expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See DHHS
Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

6. Other Submission Requirements and Information

Advance permission to submit an application is required for all FDA
conference grant applications, including new, resubmission (formerly “revision/amended”),
renewal (formerly “competing continuation”), and revision (formerly
“supplemental”) applications. Advance permission to submit an application
should be requested early in the process and no later than six weeks before the
receipt date. The letter from an FDA Center documenting advance permission to
submit an application must be submitted with the application. All applicants
must include the advance permission letter from the FDA staff member who has
agreed to accept assignment of the application. The FDA staff member granting
advance permission must be one of the contacts designated at the Conference
Grant Web site http://grants.nih.gov/grants/guide/contacts/parent_R13_U13.html)
Attach the letter as part of the PHS 398 Cover Letter component (PDF). If an
application is received without a permission letter, it will not be accepted
for review. Note that advance permission to submit an application does not
guarantee funding.

The application will be
assigned based on FDA Receipt and Referral Guidelines. This means that there
may be FDA Center dual assignments and their may be the opportunity to co-fund
the conference. Only one advance permission letter is required per application.
Dual assignments do not require advance permission to submit an application.

The following instructions
are to be used in conjunction with the SF424 (R&R) Application Guide
accompanying the SF424 (R&R) application form:

SF424 (R&R) Cover
Component. Enter the title of the conference or scientific meeting
on line item 11.

Research and Related
Project/Performance Site Locations. Enter the site of the
conference or meeting as the Performance Site.

Research and Related
Senior/Key Person: Personnel are defined as the PD/PI and those
responsible for the scientific planning and organization of the meeting. Attach
a biographical sketch for PD/PI, Co-Chair, key personnel, and confirmed key
speakers.

Research and Related Budget: The
appropriate Center/Program conference award contact should be consulted for
guidance regarding any Center/Program specific budget requirements. Enter the
direct costs requested. Provide a narrative justification for each proposed
personnel position, including role and proposed level of effort. Include
information regarding efforts to obtain funding for this conference/meeting
from other sources.

Allowable Costs:
Salary (in proportion to the time or effort spent directly on the
conference/meeting); rental of necessary equipment; travel and per diem or
subsistence allowances; supplies needed for conduct of the meeting (only if
received for use during the budget period); conference services; publication
costs; registration fees; speakers’ fees.

PHS
398 Research Plan Component: Submit one attachment, which may not
exceed 10 pages, under the Research Design and Methods section (line item 5).
Note that this section will be called “Conference Plan” in the system-generated
Table of Contents. Letters of agreement from key speakers and participants
should be attached at line item 13. Do not complete Sections 2 – 4 and the
Human Subjects Sections (Items 6-10) of the PHS 398 Research Plan.

In the “Conference Plan” section of the
application (uploaded as attachment #5), describe the objectives, specific
program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered,
problems to be addressed, and developments or contributions the meeting might
stimulate. Provide a detailed justification for the meeting, including the
scientific need, timeliness, and usefulness of the meeting to the scientific
community. Describe the composition and role of the organizing committee, and
provide the names and credentials of key participants in the meeting, including
the basis for their selection and documentation of their agreement to
participate.

Describe plans for the
appropriate involvement of women, minorities, and persons with disabilities in
the planning and implementation of the proposed meeting. Estimate the expected
size and composition of the audience, as well as the method of selection.
Describe plans for publicizing the meeting and publication of the proceedings.
Identify related meetings held on the subject during the past three years. If
this is one of a series of periodic meetings held by a permanent sponsoring
organization, briefly describe and evaluate the last meeting in the series.

Applications requesting
multiple years of support must provide the following additional information for
each future year requested, in as much detail as possible: meeting topic(s);
tentative dates, locations, and participants; and contingency plans for future
meetings dependent upon, for example, the outcome of the first year’s meeting
or developments in the field.

A critical part of the
application for FDA support of
conferences is documentation of appropriate representation of women,
racial/ethnic minorities, persons with disabilities, and other individuals who
have been traditionally underrepresented in science. These individuals must be
included in all aspects of planning, organization, and implementation of FDA
sponsored and/or supported meetings. “Appropriate representation” means
representation based on the availability of these scientists from these groups
known to be working in a particular field of biomedical or behavioral research.
If appropriate representation is not apparent, no award will be issued until
program staff is assured of concerted recruitment efforts. Organizers of
scientific meetings must document compliance with the Guidelines for Inclusion
of Women, Minorities, and Persons with Disabilities in Scientific Meetings
Supported by the NIH/FDA (http://grants.nih.gov/grants/funding/r13/index.htm).
This Web site also includes addresses and information for offices at FDA that
support conference activities.

Appendix: The
appendix is limited to announcements and reports of previous meetings under the
same sponsorship. No other information or material should be submitted as
appendices.

PHS 398 Checklist Component: The
checklist is required; however, no information regarding F&A should be
included as this is not an allowable cost for this mechanism.

Resource Sharing Plan(s)

Not applicable.

Section V.
Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review
process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the
FDA Centers on the basis of an advance permission letter. Applications lacking
such a letter will not be reviewed. Dual assignments will be made on the basis
of established PHS referral guidelines. An appropriate evaluation group
convened by the accepting Center/Program will evaluate the application for
scientific and technical merit.

The following will be considered in making funding decisions:

Scientific
merit of the proposed conference/scientific meeting as determined by the
evaluation process.

Availability
of funds.

Relevance of
program priorities.

In their critiques,
reviewers will be asked to comment on each of the following criteria, which
will be addressed and considered in assigning the overall score, weighting them
as appropriate for each application. Note that an application does not need to
be strong in all categories to deserve a high priority score.

Significance: Does this
conference/scientific meeting address an important health problem? If the aims
of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these endeavors on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Is the purpose of the conference and its
relevance to FDA clear? Is the conference timely in terms of currency of
issues to be addressed?

Approach: Is
the format and agenda for the meeting appropriate for achieving the goals of
the conference? Is the meeting timely for the subject matter? How well do the
plans for inclusion of women, minorities, and persons with disabilities provide
for their appropriate representation in the planning, organization, and
implementation of the proposed meeting?

Innovation: Does the meeting
employ novel approaches or methods to fulfill its purpose?

Investigators: Is
the PD/PI well suited for organizing and fulfilling the goals of this
conference? Are the qualifications of the PD/PI appropriate and past
performance adequate? Are the key personnel and selected speakers appropriate
and well suited for their described roles in the conference?

Environment: How appropriate is the
meeting site? Does the applicant organization have the ability to contribute to
the probability of success? Do the proposed meetings, exhibits, interactions,
etc., take advantage of unique features of the environment or employ useful
collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review
Criteria:

In addition to the above criteria, the following item will continue to be
considered in the determination of scientific merit and the priority score:

FDA affirms that the value
of scientific meetings is enhanced by including participants from all segments
of the scientific population and, when appropriate, members of the lay
community, in both the planning and conduct of such meetings. The
adequacy of plans to include women, minorities and persons with disabilities in
the planning and execution of a scientific meeting or conference is important
to its success and relevance and will be assessed.

2.B. Additional Review
Considerations

Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed plan. Does
the amount requested from FDA appear reasonable as partial support of the total
conference given the plan, facilities, travel, and speakers? The
priority score should not be affected by the evaluation of the budget.

Previous Experience: Is
there previous experience with the organization/or the principal investigator
in similar undertakings? If so, what?

2.C. Resource Sharing Plan(s)

Not Applicable.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request
"just-in-time" information from the applicant. For details,
applicants may refer to the DHHS Grants Policy Statement Part II:
Terms and Conditions of FDA Grant Awards,
http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A formal email notification
in the form of a Notice of Award (NoA) will be provided to the applicant
organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee authorized representative.

Selection of an application
for award is not an authorization to begin performance. Any costs incurred
before receipt of the NoA are at the recipient's risk. These costs may be
reimbursed only to the extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

2. Administrative and National
Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants
Policy Statement as part of the NoA. For these terms of award, see the DHHS Grants Policy Statement Part II: Terms and Conditions of FDA Grant Awards,
http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

The following Terms and
Conditions will be incorporated into the NoA and will be provided to the PD/PI
as well as to the appropriate institutional official, at the time of award.

The following special terms of award are in addition to, and not in lieu
of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and FDA grant administration policies.

The administrative and funding instrument used for this program will be
the cooperative agreement (U13), an "assistance" mechanism (rather
than an "acquisition" mechanism), in which substantial FDA
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the FDA purpose
is to support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the FDA as
defined above.

Awardees have primary
authorities and responsibilities to define objectives and approaches, and to
plan, conduct, analyze, and publish results, interpretations, and conclusions
of the conference.

The PD/PI will retain custody
of, and have primary rights to, information developed under the cooperative
agreement, subject to government rights of access, consistent with the current
DHHS, PHS, and FDA policies. Publication and copyright agreements and the
requirements for financial status reports; retention of records; and terminal
progress reports will be as stated in the HHS Grants Policy Statement
http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

Awardees will retain custody of and have primary rights to the data and
software developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and FDA policies.

Awardees are responsible for
identifying specific milestones for conferences that will be supported during
the project period, when multi-year conferences are supported.

2.A.2. FDA Responsibilities

An FDA Project Scientist will have substantial programmatic involvement
that is above and beyond the normal stewardship role in awards, as described
below.

An FDA Project Scientist
will have substantial scientific-programmatic involvement during conduct of
this activity, through technical assistance, advice, and coordination above and
beyond the normal program stewardship for grants. Substantial involvement as a
partner would include, for example, assisting in planning the agenda, selecting
speakers, organizing a symposium, determining the content of the meeting, or
determining the acceptability of submitted papers. Substantial involvement
would not include serving as an invited speaker or providing limited advice.

Additionally, an agency Program Official or Center Program Director will
be responsible for the normal scientific and programmatic stewardship of the
award and will be named in the NoA. The assigned Program Director will also serve
as the Project Scientist.

2.A.3. Collaborative
Responsibilities

Not Applicable.

2.A.4. Arbitration Process

Any disagreements that may
arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the FDA may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: one chosen by the awardee, a second member selected by the
CENTER, and the third member with expertise in the relevant area who is chosen
by the other two. This special arbitration procedure in no way affects the
awardee's right to appeal an adverse action that is otherwise appealable in
accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations
45 CFR Part 16.

3.
Reporting

When multiple years are
involved, awardees will be required to submit the PHS Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the DHHS Grants Policy Statement. Reports must be submitted two months prior to
the next budget period start date. The Progress Report should include a report
of the previous meeting supported by the current grant, as well as a full
description of the next planned meeting.

Section VII. Agency
Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into two areas:
scientific/research, and financial or grants management issues.

1. Scientific/Research Contacts:

Consult the FDA Web site, http://www.fda.gov/ and direct your questions to the appropriate individual. Issues that remain
after consultation with Center staff and that are not addressed in this FOA may
be directed to:

URLs in FDA Grant Applications
or Appendices:
All applications and proposals for FDA funding must be self-contained within
specified page limitations. Unless otherwise specified in an FDA solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of “Healthy People 2010,” a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of “Healthy People 2010”
at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

FDA's
authority to enter into grants and cooperative agreements is detailed under
title XVII of the Public Health Service Act (42 U.S.C. 300u-1) and/or the
Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) (21 U.S.C.
360hh-ss, formerly 42 U.S.C. 263b-n).